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Catalog Number DL950F |
Device Problems
Material Twisted/Bent (2981); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, a video was provided for review.The investigation of the reported event is currently underway.The catalog number identified in section has not been cleared in the us but is similar to the denali products that are cleared in the us.The pro code and 510 k number for the denali products are identified in common device name and date rec'd by mfr.(expiry date: 08/2024).
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Event Description
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It was reported that during a vena cava filter placement procedure, the filter limbs and arms were failed to expand.The procedure was completed by using another device.There was no reported patient injury.
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Event Description
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It was reported that during a vena cava filter placement procedure, the filter limbs and arms were failed to expand.The procedure was completed by using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali products that are cleared in the us.The pro code and 510 k number for the denali products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation, one electronic video imaging was provided and reviewed.The video shows an venogram from the left iliac vein demonstrates an inferior vena cava filter in place just below the right renal vein.The filter legs appear constrained and not fully expanded.The vena cava appears patent and free of thrombus.Based on the image review, the reported activation failure including expansion failures can be confirmed as deployed filter legs appear constrained and not fully expanded.A definitive root cause for the reported activation failure including expansion failures could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 08/2024).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd h3 other text : device not returned.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one femoral denali filter kit was returned for evaluation.The filter legs and arms were crossed and a rubber band was observed tied over the filter.The pusher catheter wire was observed to be bent.Although the sample was returned one electronic video imaging was provided and reviewed.The video shows an venogram from the left iliac vein demonstrates an inferior vena cava filter in place just below the right renal vein.The filter legs appear constrained and not fully expanded.The vena cava appears patent and free of thrombus.Based on the findings, the investigation is confirmed for the reported activation failure including expansion failures and the identified material bent issue.A definitive root cause for the reported activation failure including expansion failures and identified material bent issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali products that are cleared in the us.The pro code and 510 k number for the denali products are identified in d2 and g4.H10: d4 (expiry date: 08/2024), g3, h2, h6 (device, result).H11: h6 (method).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd h3 other text : see h10.
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Event Description
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It was reported that during a vena cava filter placement procedure, the filter limbs and arms were failed to expand.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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